Job Title: Pharmacy IMP Administration Assistant
Location: London Bridge, SE1 (Onsite)
Term: Permanent, Full Time
Salary: Competitive + Benefits (Private Medical, Private Dental, Life Assurance, Private Pension & many more)
Provide practical, hands-on support across Richmond Pharmacology’s marketing activities. This role is responsible for the execution of day-to-day tasks that ensure marketing campaigns, events, and communications run smoothly. The role also supports practical reputation management through updates to internal systems, digital channels, and communication tools.
Purpose of the job
To prepare, coordinate and administer unblinded investigational medicinal product (IMP) dosing activities for clinical trial participants, including IMP infusions where required, while maintaining strict blinding controls to ensure blinded clinical staff remain unaware of treatment allocation throughout the study.
The role is primarily focused on unblinded dosing support and safe, timely dosing delivery. It also includes broader pharmacy operational support for investigational and non-investigational medicinal products, including receipt, storage, dispensing, reconciliation, documentation, stock control, audit readiness and maintenance of pharmacy records in accordance with GMP, GCP, company SOPs and study-specific requirements.
Main duties and responsibilities
- Prepare and administer IMP infusions and other assigned dosing activities in accordance with the study protocol, pharmacy instructions and applicable regulatory requirements.
- Act as an unblinded member of the study team where required by the study blinding plan, ensuring treatment allocation is protected and blinded study personnel are not exposed to unblinded information.
- Prime infusion lines, set up infusion pumps, connect infusion lines, manage infusion issues, perform post-infusion flushing and disconnect infusion lines where trained and delegated to do so.
- Manage and coordinate dosing times, liaising with clinical teams and Research Physicians to ensure accurate and timely participant dosing while maintaining blinding controls.
- Support the Research Physician during dosing procedures and provide immediate practical support during participant dosing periods.
- Accurately document all dosing activities in source documents, study worksheets and relevant trial systems, ensuring entries are complete, contemporaneous and attributable.
- Review the Volunteer Database, trial schedule and pharmacy schedule in preparation for upcoming studies and daily dosing activities.
- Communicate effectively with Pharmacy, Clinical Operations and ward teams regarding dosing schedules and participant flow without disclosing unblinded information.
- Be present as Immediate Life Support safety cover while participants are in the unit, where trained and required by study or operational arrangements.
- Receive, store, handle, label, prepare and dispose of IMPs and NIMPs in accordance with GMP, GCP, company SOPs and study-specific requirements.
- Support the preparation and dispensing of sterile and non-sterile trial medication under the supervision of senior Pharmacy personnel, as appropriate to training and competence.
- Maintain accurate accountability records including drug logs, study folders, reconciliation documents, environmental records and pharmacy databases.
- Support inventory control, stock checks, procurement of trial supplies and consumables, and general pharmacy set-up activities to maintain continuity of service.
- Assist with IMP returns, destruction and reconciliation, ensuring all related documentation is completed accurately and retained appropriately.
- Contribute to the maintenance of the Pharmaceutical Quality Management System, including supporting SOP and documentation updates, audit preparation, monitor visits and regulatory inspections.
- Assist with the maintenance, calibration and qualification of pharmacy premises and equipment in accordance with approved schedules and pharmacy procedures.
- Maintain the clinical ward space used for dosing to a high standard, ensuring it remains clean, safe, organised and appropriately stocked.
- Resolve or escalate data queries and dosing-related issues raised by Clinical Compliance, External Monitors or other stakeholders.
- Maintain the Pharmacy generic email inbox and respond or escalate queries in a timely and professional manner.
- Participate in weekend, bank holiday and shift work, as required by the pharmacy rota and service needs.
- Undertake any other duties consistent with the level of the post, as directed by the Head of Pharmacy or other senior Pharmacy personnel.
Skills and Experience
- BSc degree in Life Sciences, Pharmacy, Pharmaceutical Sciences or a related discipline, or equivalent experience/knowledge.
- Basic understanding of regulatory compliance, documentation
standards
and Good Clinical Practice / Good Manufacturing Practice principles.
- Current training and competency relevant to the role, including study- and task-specific training before undertaking delegated duties.
- Experience in a pharmacy, clinical research or other regulated healthcare setting.
- Practical understanding of clinical trial dosing activities and/or medication handling,
Application:
If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.
